A mixture of Escherichia coli (DSM 17252) and Enterococcus faecalis (DSM 16440) for treatment of the irritable bowel syndrome – A randomized controlled trial with primary care physicians

Abstract

Therapy trials with bacterial compounds in irritable bowel syndrome (IBS) have produced conflicting results. This study was performed in 1988 and 1989, and was re-analysed according to current IBS standards. Two hundred ninety-seven patients with lower abdominal symptoms diagnosed as IBS were treated for 8 weeks by the compound ProSymbioflor((R)) (Symbiopharm GmbH, Herborn, Germany), an autolysate of cells and cell fragments of Enterococcus faecalis and Escherichia coli, or placebo in a double-blinded, randomized fashion. Patients were seen weekly by the physician, who assessed the presence of core IBS symptoms. Responders had at least a 50% decrease in global symptom score (GSS) and in abdominal pain score (APS) reports at >/=1 visit during treatment. The responder rate in GSS to the drug was 102/149 (68.5%) in comparison to placebo with 56/148 (37.8%) (P < 0.001), the improvement in APS was 108/149 (72.5%) and 66/148 (44.6%) respectively (P = 0.001). The number-needed-to-treat was 3.27 for GSS and 3.59 for the APS report. Kaplan-Meier analysis revealed a mean response time of 4-5 weeks for active treatment and more than 8 weeks for placebo (P < 0.0001). Treatment of IBS with the bacterial lysate ProSymbioflor is effective and superior to placebo in reducing typical symptoms of IBS patients seen by general practitioners.

Probiotic Therapy of the Irritable Bowel Syndrome: Why Is the Evidence Still Poor and What Can Be Done About It?

“…Following a full-paper review, we excluded 8 further studies due to various reasons: only 1 study reported data from prebiotic treatment, 29 1 study did not use a probiotic in a strict sense (no living bacteria), 30 2 were microbial investigations of earlier studies, 31,32 2 were single-blinded, 33,34 and 2 were uncontrolled interventions. 35,36 Based on hand-searches of the published meta-analyses, we added 3 more studies, [37][38][39] resulting in a total of 55 articles.…”

Using Probiotics Instead of Pharmaceuticals to Treat Gastrointestinal Disorders

“…If the probiotics are shown to be effective as they have been in initial studies [21], they should be used in place of the current medications when possible. Probiotics are healthy bacteria that are a part of the human digestive tract; using them to treat gastrointestinal disorders and help return the gut to a state of homeostasis is preferable to introducing medications that will further eradicate the healthy gut bacteria and increase the risk of more serious gastrointestinal distress [30][31][32]. As Horveth discusses, individual strains need to be tested first and then probiotic combination therapies to develop effective probiotics to treat gastrointestinal disorders [21].…”

Quantitative Risk–Benefit Analysis of Probiotic Use for Irritable Bowel Syndrome and Inflammatory Bowel Disease

“…Only three published trials assessed ADEs related to probiotics in IBS in any systematic or standardized way. (27,29,34) A recent metaanalysis(39) showed a pooled relative risk (RR) for an adverse event of any type across all published trials of 1.21 (95% CI 1.02-1.44) and number needed to harm was 35. 16.5% of patients in all trials had an ADE on probiotics, compared with 13.8% of controls.…”

“…First, we constructed a dataset using all existing clinical trials that reported both efficacy and adverse drug events for both IBS (24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38) or IBD(40-49), as described in Figure 1 and Table 1. We sampled across the 95% confidence intervals for each trial weighted by the size of the trial (larger trials had a larger share of sampling).…”